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New Substances Notification (NSN) Reporting Form For Micro-organisms


(Microsoft Word Version - 273 KB)

Table of Content

Introduction

This form is to be used for fulfilling the information requirements prescribed in the New Substances Notification Regulations (Organisms) [NSNR (Organisms)] of the Canadian Environmental Protection Act, 1999 (CEPA 1999) when notifying a micro-organism. If you are notifying an organism other than a micro-organism, please use the New Substances Notification (NSN) Reporting Form for organisms other than a micro-organism.

The NSN package must be submitted to:

Mailing Address:
Executive Director, Program Development and Engagement Division
Department of the Environment
Ottawa ON, K1A 0H3

Courier Deliveries:
Executive Director, Program Development and Engagement Division
Department of the Environment
8th Floor, Fontaine Building
200 Sacré-Coeur Blvd.
Gatineau QC, J8Y 3Y5

Departmental Use Only

NSN Reference No.:

_________________________

Date Received:

_________________________

Mail Log:

_________________________

Total number of pages:

_________________________

Instructions for Completing the Notification Form

The NSN Reporting Form serves as an aid for complying with the NSNR (Organisms) of CEPA 1999. Notifiers may reproduce this form, or portions thereof, for notification purposes. The form is also available electronically from the New Substances website.

Additional explanations necessary for fulfilling prescribed information requirements and completing this notification form are included in the Guidelines for the Notification and Testing of New Substances: Organisms. Hard copies of the Guidelines may be obtained from Environment Canada, for a fee, by contacting the Substances Management Information Line at 1-800-567-1999 (toll free in Canada), or (819) 953-7156 for callers outside of Canada; or via substances@ec.gc.ca. The Guidelines are also available on the aforementioned New Substances ­website.

This form is divided into parts A, B and C. Part A is for administrative and organism identity information, Part B is for technical information, and Part C is for additional information.

Before completing parts B and C, you should ensure that you are providing information that is appropriate for the notification group under which the organism you intend to import or manufacture is being notified (see section 3 of the Guidelines for the Notification and Testing of New Substances: Organisms). Part B contains six sections listing the information items required for each notification group. This list functions only as a checklist; it is expected that the information will be provided as attachments. These six sections are: (1) General Information Requirements in regards to micro-organisms; (2) Importation or Manufacture Information Requirements; (3) Introduction Information Requirements; (4) Environmental Fate Information Requirements; (5) Ecological Effects Information Requirements; and (6) Human Health Effects Information Requirements. Part C contains one section: Additional Information Requirements. Parts B and C contain four columns: Submit with Schedule; Data Codes; Attachment Number; and Confidential Information. Explanations of the use of these columns are provided on page 2 of this form.

Ce formulaire est disponible en français, sur demande, en communiquant avec La ligne d’information des déclarations de substances nouvelles au 1-800-567-1999 (sans frais au Canada) ou au (819) 953-7156 (de l'étranger). Le formulaire est aussi disponible électroniquement au sur le site Web des substances nouvelles.

Data Codes, Attachments and Confidential Information

In addition to the list of information requirements, parts B and C contain four columns: Submit with Schedule; Data Codes; Attachment Number; and Confidential Information. The following explains the use for each of these columns.

Submit with Schedule: This is a quick reference column that allows you to determine, at a glance, which schedule requires the information to be provided. Take note of the footnotes for certain exceptions and conditions associated with certain data elements.

Data Codes: Each information item in this column should be marked with one of the codes noted below. These codes will allow government officials to quickly identify the type of information provided and whether a request for a waiver of information is being submitted.

  • D = Test data
  • S = Surrogate organism
    This refers to data or other information in respect of an organism closely related to the organism being notified (scientific rationale should be provided). The taxon of the surrogate organism should be specified. Consultation with Environment Canada and Health Canada is recommended before deciding to provide data or information on a surrogate organism.
  • O = Other information
    This code is used for peer-reviewed literature, unpublished reports and descriptive information.
  • W = Waiver requested
    A request for a waiver of information should be accompanied by a justification that satisfies one of the criteria in subsection 106(8) of CEPA 1999.
  • None = No Information in itself
    An example of the correct use of this code would be to indicate none where no patent or patent application exists.
  • P = Previous notification
    This code is to be used if the notifier has already provided the information to Environment Canada in a previous NSN or a notice under section 70 of CEPA 1999. Enter the applicable NSN or CEPA 1999 section 70 reference number in the attachment column.

Attachment Number: Notifiers must clearly indicate a reference for accompanying documents (e.g., Attachment 6), so that they may be readily located within the NSN package. Attachments include: justifications for waivers of information; reports of experimental procedures; reports of test results; rationale for alternative data; results and validation of modelling studies; and information supplemental to a request for confidentiality.

Confidential Information: Notifiers must check the appropriate box to indicate that the information provided is considered confidential (i.e., check "Y" to indicate that the information is considered confidential or check “N” to indicate that the information is not confidential). If the information is considered confidential, the notifier should attach supplementary information specified in section 8 of the Guidelines for the Notification and Testing of New Substances: Organisms. Use square brackets, i.e., [  ], to indicate the specific text or figure that is considered confidential.

Part A – Administrative and Substance Identity Information

A.1 – Certification Statement

I hereby certify to the best of my knowledge that all information provided in this form, as well as any attachments to the form, are accurate and complete; and that the information for which confidentiality is claimed meets the criteria for determining confidentiality as outlined in section 8 of the Guidelines for the Notification and Testing of New Substances: Organisms.

Name and title of the person authorized to act on behalf of the corporation of block A.2 or A.3:

______________________________________________________

Signature:

______________________________________________________

Date (YYYY/MM/DD):

______________________________________________________

Name and title of the person in Canada authorized to act on behalf of the corporation of block A.4 (if applicable):

______________________________________________________

Signature:

______________________________________________________

Date (YYYY/MM/DD):

______________________________________________________

Preferred Language of Correspondence:  English,  French

Preferred Mode of Communication for Correspondence:  Mail,  Facsimile (non-secure)

A.2 – Corporate Headquarters of the Canadian Manufacturer or Importer (Principal Place of Business in Canada)

(if the importer is not located in Canada, skip to block A.3)

Company Name:

______________________________________________________

Email:

______________________________________________________

Street:

______________________________________________________

City:

______________________________________________________

Province:

______________________________________________________

Postal Code:

______________________________________________________

Telephone No.: (______) - ______________

Facsimile No.: (______) - ______________

A.3 – Corporate Headquarters of the Non-resident Importer

(if A.3 is applicable, also complete block A.4)

Company Name:

______________________________________________________

Email:

______________________________________________________

Street:

______________________________________________________

City:

______________________________________________________

State/Country:

______________________________________________________

Zip / Postal Code:

______________________________________________________

Telephone No.: (______) - ______________

Facsimile No.: (______) - ______________

A.4 – Canadian Agent

(only needed if block A.3 is applicable)

Company Name:

______________________________________________________

Email:

______________________________________________________

Street:

______________________________________________________

City:

______________________________________________________

Province:

______________________________________________________

Postal Code:

______________________________________________________

Telephone No.: (______) - ______________

Facsimile No.: (______) - ______________

A.5 – Foreign Supplier

(only needed if the technical information in Part B is provided by a third party)

Company Name:

______________________________________________________

Email:

______________________________________________________

Street:

______________________________________________________

City:

______________________________________________________

State/Country:

______________________________________________________

Zip / Postal Code:

______________________________________________________

Telephone No.: (______) - ______________

Facsimile No.: (______) - ______________

A.6 – Proposed Site of Manufacture in Canada / Proposed Port of Entry into Canada

Company Name / Port of Entry:

______________________________________________________

Contact Name:

______________________________________________________

Street:

______________________________________________________

City:

______________________________________________________

Province:

______________________________________________________

A.7 – Technical Contact

(name of a person who can assist in the resolution of issues pertaining to the information provided)

Person’s Name/Title:

______________________________________________________

Email:

______________________________________________________

Street:

______________________________________________________

City:

______________________________________________________

Province/State / Country:

______________________________________________________

Zip/Postal Code:

______________________________________________________

Telephone No.: (______) - ______________

Facsimile No.: (______) - ______________

A.8 – Previous NSN Reference Number if this organism has been previously notified by you

______________________________________________________

Pre-Notification Consultation (PNC) Reference Number (if applicable):

______________________________________________________

A.9 – Activity

 Manufacture
 Import
 Manufacture and Import

A.10 – Date that the Organism is Expected to be Imported or Manufactured

Date (YYYY/MM/DD):

______________________________________________________

A.11 – Micro-organism Information

  • Is the micro-organism solely for Foods and Drugs Actuse?
     Y or  N

  • Is the micro-organism a Research & Development Organism?
     Y or  N

  • Is the micro-organism or its use in Canada regulated under any other federal act?
     Y or  N

    If yes, provide the name of the act:

    ___________________________________________________________

  • Is the micro-organism a known plant, human or animal pathogen?
     Y or  N

  • What is the biosafety level of the micro-organism?
     I, II,  III or  IV

    If the biosafety level is III or IV, was an import permit or an approval in writing to transfer granted in respect of the micro-organism under the Human Pathogens Importation Regulations?
     Y or  N

  • Quantity for import:
     < 50 mL or 50 g
     > 50 mL or 50 g
     Not for Import

  • Quantity for manufacture:
     < 250 L
     > 250 L and < 1000 L
     > 1000 L
     Not for manufacture

  • Type of organism:
     Bacterium
     Fungus
     Protist
     Archea
     Consortium
     Virus, virus-like particle or sub-viral particle
     Cultured plant or animal cell

A.12 – Proposed Explicit Biological Name

(if the space provided below is not sufficient, please provide the information as a separate attachment)

___________________________________________________________

 Supplementary Information Enclosed
Attachment Number: ______________

A.13 – Proposed Masked Name if the Explicit Biological Name has been Claimed as Confidential

(if the space provided below is not sufficient, please provide the information as a separate attachment)

___________________________________________________________

 Supplementary Information Enclosed
Attachment Number:______________

A.14 – Notification Group

  • Introduction anywhere in Canada (provide all information in Schedule 1)

  • Introduction into an ecozone where it is not indigenous [provide all information in Schedule 1[1] and additional information in paragraph 3(2)(a) of the NSNR (Organisms)]
    Attachment Number: ______________

    Intended ecozone of introduction:

    ______________________________________________________

    Introduction outside of the above-listed ecozone but within 10 km of the ecozone boundary:
     Y or  N

    If yes, provide the information in paragraph 3(3) of the NSNR (Organisms)
    Attachment Number :______________

  • Introduction in accordance with confinement procedures [provide all information in Schedule 1[2] and additional information in paragraph 3(2)(b) of the NSNR (Organisms)]
    Attachment Number: ______________

  • Introduction into an ecozone to which it is indigenous [provide all information in Schedule 1[3] and additional information in paragraph 3(2)(c) of the NSNR (Organisms)]
    Attachment Number: ______________

    Intended ecozone of introduction:

    ______________________________________________________

    Introduction outside of the above-listed ecozone but within 10 km of the ecozone boundary:
     Y or  N

    If yes, provide the information in section 3(3) of the NSNR
    Attachment Number: ______________

  • Introduction in a contained facility or for export only (provide all information in Schedule 2)

    Containment level of the facility:

    ______________________________________________________

  • Introduction in an experimental field study (provide all information in Schedule 3)

  • Reintroduction at the same site where the substance was extracted from (provide all information in Schedule 4)

A.15 – Confidentiality Requests

Corporation:  Y or  N

Manufacture:  Y or  N

Import:  Y or  N

Amount:  Y or  N

Substance Identity:  Y or  N

A.16 – Information-Sharing-Agreement Authorization

I hereby grant the Minister of the Environment permission to release the name, address and phone number of the technical contact indicated in block A.7 of this form to any person who has provided the Minister of the Environment with: (1) documentation of intent to manufacture or import the substance described in block A.12 of this form; and (2) a statement granting the Minister of the Environment permission to release the name, address and phone number of their technical contact.

Name and Title:

______________________________________________________

Signature:

______________________________________________________

Date (YYYY/MM/DD):

______________________________________________________

Part B – Technical Information

B.1 – General Information Requirements in Respect of the Micro-organism

RequirementSubmit with ScheduleData CodeAttachment / No.Confidential Information
The identification and the information substantiating the identification1,2,3,4   Y or  N
Common and superseded names and any synonyms1,2,3   Y or  N
The strain history1,2,3   Y or  N
A description of any modifications made to the organism, including
(i) the purpose of the modifications1,2,3   Y or  N
(ii) the methods and steps taken to make the modifications1,2,3   Y or  N
(iii) the phenotypic and genotypic changes that resulted from the steps referred to in (ii)1,2,3   Y or  N
(iv) the stability of the changes referred to in (iii)1,2,3   Y or  N
(v) the nature, source and function of any inserted genetic material1,2,3   Y or  N
A description of the methods that can be used to distinguish and detect the micro-organism1,2,3   Y or  N
A description of the biological and ecological characteristics of the micro-organism, including
(i) its life cycle1[4],3[5]   Y or  N
(ii) its infectivity, pathogenicity to non-human species, toxicity and toxigenicity1,2,3,4   Y or  N
(iii) its resistance to antibiotics and tolerance to metals and pesticides1[4],3[5]   Y or  N
(iv) its involvement in biogeochemical cycling1[4],3[5]   Y or  N
(v) the conditions required for, and conditions that limit, survival, growth and replication1,2,3   Y or  N
(vi) the mechanisms of its dispersal and the modes of interaction with any dispersal agents1,3   Y or  N
A description of the mode of action in relation to the intended use (or in relation to the objective of the experimental field study)1,2,3   Y or  N
The identification of any patent or any application for a patent1,2,3   Y or  N
The dispersal by gene transfer of traits of pathogenicity, toxigenicity and resistance to antibiotics, including a description of:
(i) the genetic basis for pathogenicity to non-human species, toxigenicity and resistance to antibiotics1[4],3[5]   Y or  N
(ii) the capability to transfer genes1[4],3[5]   Y or  N
(iii) the conditions that might select for dispersal of traits of pathogenicity to non-human species, toxigenicity and resistance to antibiotics, and whether the conditions are likely to exist at the locations of introduction (or at the site of the experimental field study) or within the range of dispersal of the micro-organism1[4],3[5]   Y or  N
A description of the geographic distribution of the micro-organism1,3   Y or  N
A description of the reasonably expected by-products following introduction4   Y or  N

B.2 – Importation or Manfufacture Information Requirements

RequirementSubmit with ScheduleData CodeAttachment / No.Confidential Information
The identification of trade names and manufacturers, importers and vendors1,2,3   Y or  N
The identification of locations of manufacture in Canada1,2   Y or  N
The containment level for each manufacturing facility in Canada or for each facility to which the micro-organism will be imported, determined in accordance with the physical and operational requirements set out in either the Laboratory Biosafety Guidelines or Appendix K of the NIH Guidelines2   Y or  N
The physical state of the formulation1,3   Y or  N
The concentration of the micro-organism in the formulation1,3   Y or  N
The identification and concentration of other ingredients and of any contaminants in the formulation1,3   Y or  N
The viability of the micro-organism in the formulation1,3,4   Y or  N
A description of any recommended storage and disposal procedures1,2[6],3   Y or  N
An estimation of the quantity of the micro-organism that will be imported into or manufactured in Canada1,2,3,4   Y or  N
A description of the equipment and methods of manufacture, and of quality control and quality assurance procedures1,2,3,4   Y or  N
A description of the location of manufacturing facilities in Canada1,3   Y or  N
A description of the nature of potential releases of the micro-organism from the manufacturing facilities in Canada or from faciltiies to which the micro-organism will be imported, and the procedures to control releases1,3   Y or  N
A description of the procedures for the treatment and disposal of wastes containing the micro-organism from the manufacturing facilities in Canada1,3,4   Y or  N
Data to substantiate that the micro-organism was isolated from the site of introduction4   Y or  N

B.3 – Introduction Information Requirements

RequirementSubmit with ScheduleData CodeAttachment / No.Confidential Information
The intended and potential uses1,2,4[7]   Y or  N
The following information in respect of the experimental field study (or introduction)
(i) the objectives3   Y or  N
(ii) its start and duration3,4   Y or  N
(iii) a description of the procedures for transporting the micro-organism to and from the site of the experimental field study3   Y or  N
The history of use of the micro-organism1,2,3   Y or  N
A description of the procedures for the introduction of the micro-organism (or a description of the procedures and design for the experimental field study),  including:
(i) the method of application of the micro-organism1,3,4   Y or  N
(ii) the quantity, frequency and duration of application of the micro-organism1,3,4   Y or  N
(iii) any activities associated with the introduction (or with the experimental field trial)1,3,4   Y or  N
A comparison of the natural habitat of the micro-organism to the habitat at the potential locations of its introduction (or at the site of the experimental field study), and the nature of the selection that may operate on the micro-organism at the potential locations of introduction (or at the site of the experimental field study)1,3   Y or  N
The following information in respect of the site of the experimental field study (or site of introduction):
(i) its location and a map3,4   Y or  N
(ii) its size3   Y or  N
(iii) the distance to populated areas3   Y or  N
(iv) the distance to any protected areas3   Y or  N
(v) a description of the geological landscape at the site and surrounding the site3   Y or  N
(vi) a description of the biological diversity found at the site and surrounding the site, including:
3   Y or  N
(a) the identification of the endangered or threatened species    Y or  N
(b) if infectivity, pathogenicity to non-human species, toxicity and toxigenicity have been identified, the identification of the receptor species3   Y or  N
A description of any contingency plans in the event of an accidental release1,3   Y or  N
A description of any recommended procedures for terminating the introduction of the micro-organism (or the experimental field study)1,3   Y or  N
A description of any confinement procedures and biosafety conditions for the micro-organism at the site of the experimental field study (or site of introduction), and a description of their effectiveness3, 4   Y or  N
A description of any procedures for monitoring the micro-organism and its ecological effects at the site of the experimental field study, during and after the experimental field study3   Y or  N
A description of the security measures at the site of the experimental field study3   Y or  N
The identification of the ecozone of intended introduction1[8]   Y or  N
If the micro-organism is indigenous to the ecozone of introduction (or at the site of the experimental field trial), data to demonstrate that it is indigenous1[9],3   Y or  N
A description of those confinement procedures and their effectiveness in restricting the exit or dispersal of the micro-organism from the locations of introduction1[10]   Y or  N

B.4 – Environmental Fate Information Requirements

RequirementSubmit with ScheduleData CodeAttachment / No.Confidential Information
The identification of the plant and animal species likely to be exposed and, if infectivity, pathogenicity to non-human species, toxicity and toxigenicity have been identified, the identification of the receptor species likely to be exposed1   Y or  N
A description of habitats where the micro-organism may persist or proliferate1,3   Y or  N
The estimated quantities of the micro-organism in the air, water and soil at the points of introduction, and the estimated population trends1,3   Y or  N
Any other information on the environmental fate of the micro-organism1,3   Y or  N

B.5 – Ecological Effects Information Requirements

RequirementSubmit with ScheduleData CodeAttachment / No.Confidential Information
The data from tests conducted to determine the effects of the micro-organism on
(i) aquatic plant, invertebrate and vertebrate species likely to be exposed to it, and1[11]   Y or  N
(ii) terrestrial plant, invertebrate and vertebrate species likely to be exposed to it1[11]   Y or  N
The data from tests conducted to determine the effects of the micro-organism on plant, invertebrate and vertebrate species likely to be exposed1[12]   Y or  N
The involvement of the micro-organism in adverse ecological effects1,3   Y or  N
The potential of the micro-organism to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity1,3   Y or  N

B.6 – Human Health Effects Information Requirements

RequirementSubmit with ScheduleData CodeAttachment / No.Confidential Information
Any documented involvement of the micro-organism in adverse human health effects and a description of the characteristics of the micro-organism that distinguish it from known pathogens1,2,3,4   Y or  N
The data from tests of antibiotic susceptibility1,2,3   Y or  N
The data from tests of pathogenicity that are valid for related micro-organisms that are pathogenic to humans1[13]   Y or  N
The potential for adverse immunologic reactions in persons exposed to the micro-organism113   Y or  N
The estimated number of persons that may become exposed and the degree of their exposure to the micro-organism1,3,4   Y or  N

Part C – Additional Information Requirements

C – Additional Information Requirements

RequirementSubmit with ScheduleData CodeAttachment / No.Confidential Information
All other information and test data in respect of the micro-organism that are relevant to identifying hazards to the environment and human health and that are in the person’s possession or to which the person ought reasonably to have access1,2,3,4   Y or  N
The identification of other government agencies, either outside or within Canada, that the person has notified of the manufacture or importation of the micro-organism, and the purpose of that notification1,2,3,4   Y or  N
A description or specification of the test procedures followed in developing the test data, including the test methods, reference substances and quality control and quality assurance procedures1,2,3,4   Y or  N

Footnotes

[1] Except paragraph 5(a) of the NSNR (Organisms)
[2] Except paragraph 5(a), 6(c)(d) of the NSNR (Organisms)
[3] Except subparagraph 1(f)(i)(iii)(iv) and paragraphs 1(i) and 5(a) of the NSNR (Organisms)
[4] Not required for notification under paragraph 3(2)(c) of the NSNR (Organisms)
[5] Required only if the micro-organism is not indigenous to the ecozone where the field trial is located
[6] Only a description of recommended storage procedures is required for Schedule 2
[7] Only intended use is required for Schedule 4
[8] Required for notifications under paragraph 3(2)(a) and (c) of the NSNR (Organisms)
[9] Required for notifications under paragraph 3(2)(c) of the NSNR (Organisms)
[10] Required for notifications under paragraph 3(2)(b) of the NSNR (Organisms)
[11] Not required for notifications under paragraph 3(2)(b) or (c) of the NSNR (Organisms)
[12] Required only for notifications under paragraph 3(2)(a) of the NSNR (Organisms)
[13] Not required for notifications under paragraph 3(2)(a)(b) of the NSNR (Organisms)


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